ABSTRACT The Biostatistics and Data Management Core provides a broad array of statistical services in support of the four projects. The Core will provide advice on clinical trial design - such as selection of end points and possible stratification, consideration and calculation of sample size and statistical power. The Core is responsible for all aspects of data management in all four projects in this proposed Program Project (P01), ?Consortium on Methods Evaluating Tobacco (COMET): Filter Ventilation and Product Standards?; we use secure databases with strong emphasis on data integrity and data quality. The Core will form plans and perform expert statistical analyses in a standardized format consistent between Projects using techniques that are state of the art. The Core will also facilitate data sharing between projects in the Center as well as the general scientific community. The Core is staffed by a biostatistician serving as Protocol Manager (Data Manager) and four highly experienced biostatisticians who have daily working relationships with all principal investigators; two of the four biostatisticians are senior faculty (Associate Professors) of the Division of Biostatistics. The Core biostatisticians have been an integral part in the development of this application and have participated with this productive group of investigators the last 4-5 years of this current COMET grant. Additionally, the Core includes one biostatistician and one bioinformaticians at The Ohio State University who will focus on conducting studies involving complex multi-dimensional datasets. The primary objective of the Biostatistics and Data Management Core is to contribute to the science and operation of the program project by participating fully in its activities. Core biostatisticians have broad long- standing expertise in clinical trial design, data collection, data storage, data retrieval, data analysis, and interpretation of results incorporating novel and complex statistical procedures as needed. By providing expertise research methodology and logistical support to data analytic activities with all three projects, this Core will help to enhance data interpretation and scientific productivity.